November 2003 daily update archive

A Russian researcher has died after sticking herself with a needle containing the Ebola virus, said her organization. The lab accident occurred on May 5, when Antonina Presnyakova was conducting research on Ebola, said a spokeswoman for the Vektor State Research Center of Virology and Biotechnology outside Novosibirsk in central Siberia. Efforts to save Presnyakova failed and she died May 19 at a special hospital located at the center. Research and medical personnel who were in contact with Presnyakova during her treatment will remain under observation for three weeks. Vektor was conducting research on the Ebola and Marburg viruses to develop vaccines for the diseases. Along with the U.S. Centers for Disease Control and Prevention, Vektor is one of only two places on earth with official stockpiles of smallpox.

Even hospitals with small intensive care units (ICU) would save money by implementing the intensive care unit (ICU) physician staffing standard, according to an article in the June issue of Critical Care Medicine. “Using conservative cost estimates, annualized savings available to hospitals with small, six bed ICU are $500,000, a 12 bed ICU $2 million and an 18 bed ICU $3 million,” said lead author Peter J. Pronovost, M.D., Ph.D., associate professor of anesthesiology and critical care, surgery, health policy and management, as well as medical director of the Center for Innovations in Quality Patient Care at The Johns Hopkins University School of Medicine in Baltimore. The figures include the salaries of the ICU physicians, or intensivists, who are board certified in a medical specialty such as surgery, internal medicine, pediatrics, or anesthesiology, and have received special training and subspecialty certification in critical care. They are dedicated to the ICU and remain on the unit for the duration of their assigned coverage. The Leapfrog Group's intensive care unit physician staffing standard requires ICUs to have a dedicated intensivist present in the ICU at all times during the day and immediately available at night by pager. Implementation of dedicated intensivist staffing in non-rural American adult intensive care units is estimated to save 162,000 lives annually. A targeted survey of hospitals revealed that dedicated intensivist staffing is currently employed in only 10 percent - 20 percent of U.S. ICUs. “In addition to reducing costs, intensivist staffing has repeatedly proven to be one of the most effective critical care interventions,” said Dr. Pronovost. “It reduces hospital mortality by 30 percent.”

Providers, suppliers, and group purchasing organizations (GPOs) participating in Global Healthcare Exchange, LLC (GHX) have launched a collaborative initiative to expand the use of Universal Product Numbers (UPNs) in the healthcare supply chain. The initiative is designed to help all members of the healthcare supply chain increase their use of UPNs, whether they are just getting started or already capable of transacting business electronically with UPNs, and will include several pilot efforts involving both buyers and sellers. UPNs, which uniquely distinguish products at a specific unit of measure, are considered fundamental to the effective use of barcoding and other electronic product identification technology designed to improve patient safety, inventory management, and supply chain efficiencies. Linda Nicoletti, Project Manager for 3M Health Care, is assisting with efforts to measure the value of UPNs to both buyers and sellers, using the Six Sigma process employed by 3M, General Electric, and many other leading healthcare organizations. More than half of the organizations represented at the GHX Content Summit agreed to adopt, implement, and/or leverage UPNs in some capacity, depending on technology and business practices; a smaller, core group will participate in the pilots.

Zarlink Semiconductor announced that Given Imaging Ltd., maker of a swallowable camera capsule for diagnosis of disease of the gastrointestinal tract, is now using an ultra low-power transmitter chip from Zarlink in its M2A capsule endoscope. The M2A capsule consisting of a microchip camera, light-emitting diodes that act as a flash, Zarlink's RF transmitter chip, antenna and two silver-oxide batteries is swallowed by the patient and then passes naturally through the digestive tract. The camera's images are relayed by the RF transmitter to a data recorder in a belt worn by the patient, who is free to continue with normal daily activities throughout the exam. Data is then downloaded to a workstation equipped with proprietary image processing software, and a video of the gastrointestinal tract is produced revealing pathologies and diseases of the small intestine that were previously undetected by traditional diagnostic tools. Published medical articles conclude that capsule endoscopy has a higher diagnostic yield than traditional, invasive methods in diagnosing patients with gastrointestinal disorders of the small intestine, including Crohn's Disease and small bowel cancer. Given Imaging's capsule endoscopy technique has already been used to diagnose thousands of patients in the USA, Canada, Europe, Asia and Australia.

China says four volunteers are in good health, several days after being injected with an experimental vaccine for Severe Acute Respiratory Syndrome. The official news agency, Xinhua, reported Wednesday that the three men and one woman, all university students, have been undergoing blood tests and temperature checks since their injections on Saturday. China says it is the first country to test a SARS vaccine on humans. All four volunteers are to be monitored over the next six months. They are the first of 36 volunteers to test the vaccine. All of them are between the ages of 21 and 40. It is not clear when the next round of injections will take place. Scientists caution that even if these tests are successful, it will be at least a year before a SARS vaccine is ready for the general public.

Abbott Vascular Devices, a division of Abbott Laboratories, announced the unveiling of the StarClose Vascular Closure System, a circumferential clip-based vascular close device, at the 2004 Paris Course on Revascularization (PCR) held in Paris, France. StarClose features a Nitinol(TM) clip that is designed to promote the primary healing process to achieve a secure close of femoral artery access sites following diagnostic or interventional vascular procedures. This clip provides 360 degree tissue apposition for rapid healing and immediate hemostasis. StarClose received CE Certification in February 2004, and is available for sale in the European Economic Communities. The device requires only four clicks to achieve a secure, “extravascular” close, which means that nothing is left inside the artery itself. The clip closes the closure site entirely from the outside of the vessel. The StarClose system allows physicians to close the artery through the introducer sheath; and allows the interventionalist to use the same pathway established during the catheterization procedure to deliver the StarClose clip directly to the puncture site. StarClose is currently an investigational device in the U.S. and is not available for sale.

St. Camillus Health System, Inc., a Catholic non-profit long-term care provider in Wauwatosa, WI, has signed a three-year contract with Johnson Controls, Inc. for management of plant operations and maintenance at its facilities, which cover approximately 550,000 square feet. The contract will provide St. Camillus with $250,000 in annual cost savings and revenue enhancement during the term of the agreement. Under the contract, Johnson Controls is responsible for managing the security systems, housekeeping, and laundry operation. The company is also providing on-site management and maintenance personnel to oversee and perform all building maintenance, including HVAC equipment and operations, apartment turnover, building automation systems, electrical systems, plumbing, utility management, and grounds and construction management.

Have a safe and happy holiday and we’ll see you June 1 with more daily updates!

Unless crude oil prices stabilize at substantially lower prices, U.S. hospitals could see further erosion in their operating margins due to large price increases for many products, warns Joe Colonna, CEO of Seattle-based Strategic Initiatives In Healthcare, LLC (SIH), a firm specializing in non-labor expense management. According to Colonna, “Many of the products used by hospitals are derived from crude oil, especially the myriad of disposables. We are watching this situation very carefully because it can ripple throughout the supply chain. While temporary fluctuations in crude oil prices are usually absorbed by the manufacturers, if crude oil prices remain near $35. a barrel, I cannot imagine how manufacturers could maintain decent profit margins without increasing prices. The real dilemma for manufacturers is the contracts they have with many group purchasing organizations are based on firm prices for a specific period. Already, we expect to see many prices to increase sharply when current contracts expire and those increases will be attributable to raw material costs incurred prior to the recent upturn in crude oil prices.” “If crude oil prices remain at or near their current levels, hospitals may want to reconsider their past decisions to convert to disposables for the sake of expense reduction”, Colonna said. SIH sees the role of supply chain and material managers expanding dramatically in the near future to assist their organizations with the management of all non-labor expenses.

Health insurer Aetna Inc. has filed a lawsuit against Abbott Laboratories Inc. for raising the price of its AIDS drug, Norvir, by 400 percent, said an Aetna lawyer. Aetna is seeking class-action status, and is the first health insurer to join the price hike battle. Filed on Tuesday in federal court for the Northern District of California in San Francisco, the suit alleges antitrust violations and seeks an unspecified amount of damages from Abbott. The suit follows a National Institutes of Health hearing on Tuesday which considered invoking a 1980 law to grant licenses for cheaper, generic versions of Norvir years before the patent expires.

A new study being published in the New England Journal of Medicine is raising questions about the results of P.S.A. blood tests as a screening for prostate cancer. The P.S.A. test looks for prostate specific antigen, a protein released by prostate cells. P.S.A. levels in the blood tend to rise when the prostate gland enlarges. The test was initially used to look for recurrences of cancer after men had been treated. In the 1990's it became popular as a screening test to find new cancers. Cancer experts generally agreed that when a P.S.A. test finds more than four nanograms of the protein in a milliliter of blood, doctors should recommend biopsies to see if cancer is present. When a biopsy finds cancer, almost all men opt for treatment, usually surgery or radiation. The study reports that as many as 15 percent of men with P.S.A. levels less than 4 had cancer when their prostates were assessed with biopsies. While higher P.S.A. levels confer greater risk, there appears to be no level at which there is no risk of prostate cancer, said the lead investigator, Dr. Ian M. Thompson, chief of urology at the University of Texas Health Science Center in San Antonio. The study, which involved 2,940 men aged 62 to 91, was not designed to show what cutoff should be used for P.S.A. levels. In the study, among the men with P.S.A. levels less than 4 whose biopsies showed cancer, 14.9 percent had high-grade cancers.

A study by Australian and New Zealand investigators finds it makes no difference whether saline or albumin, a component of human blood, is used to resuscitate critically ill patients. The findings published in the May 27 issue of the New England Journal of Medicine said the risk of dying was no higher among intensive care patients who got albumin than among those who received saline. The "Saline versus Albumin Fluid Evaluation" (SAFE) is said to be the largest study ever attempted in intensive care. The study was prompted by 1998 research published in the British Medical Journal that suggested albumin caused an increased death rate among critically ill patients. Investigators recruited almost 7,000 patients who had been admitted to 16 intensive care units (ICUs) in Australia and New Zealand. The patients randomly received either 4 percent albumin or normal saline for fluid resuscitation over the course of 28 days or until they were discharged or died. There were 726 deaths in the albumin group, vs. 729 deaths in the saline group. The proportion of patients who suffered single- or multiple-organ failure was also similar. Researchers also found no significant difference in the number of days that patients spent in the ICU. The study provided limited evidence that treatment with saline may be better for patients with brain injuries and that albumin may be the safer choice for patients with severe infections. The authors said further study is needed to determine whether one fluid or the other is better for special populations of critically ill patients.

According to a Frost & Sullivan report, cardiac MR will soon replace the traditional x-ray as the preferred imaging modality in the field of Cardiac Angiography with a recent breakthrough in the Cardiac Imaging Field. MR imaging technique can now be used to capture the images of blood flow through the vessels. The data acquisition and imaging can be obtained by adjusting the radio frequency of the scanner. This “tags” the protons present in the water of the blood cells which can be viewed as they pass through the scanner’s plane. This is a non-invasive method, meaning introduction of contrast media is completely avoided. The images obtained from this method are identical to that of x-ray angiography. This technique is called Global Coherent Free precession. It can be used to provide anatomic information such as stenotic severity and effects of stenosis of blood. The MRI equipment manufacturers only need to provide a specialized software and the same equipment can then be used for routine clinical procedure. Once this is done it would be advantageous to the healthcare providers as they could use the same MR scanner for normal and also for cardiac scanning instead of x-ray angiography.

Hospitals participating in a supply chain improvement collaborative project through the Premier alliance have reported $22 million in savings from process improvements in areas such as contract administration, the cardiac cath lab, pharmacy, and perioperative services. The Third Annual Supply Chain Collaborative Breakthrough Series involved teams from 28 leading healthcare organizations. Six teams reported savings of more than $1 million each. Total savings were 65 percent higher than the original goal. Said Premier's Gay Wayland, R.N., vice president, Supply Chain Knowledge Transfer, “Traditionally, the director of materials management and the perioperative services director rarely get a chance to collaborate. This project really opens the door of the OR for the materials manager.” The Supply Chain Collaborative Breakthrough Series is an annual initiative available to members of Premier, Inc. Among the hospitals achieving savings of more than $1 million were St. Francis Hospital, Tulsa, OK ($4.7 million) and Carle Foundation Hospital, Urbana, IL ($1.1 million). Later this summer, Premier will make publicly available a white paper documenting the methods used by participants to achieve the savings. The fourth annual Supply Chain Collaborative Breakthrough Series starts in September.

Reuters Health reports that a presentation at the 104th General Meeting of the American Society for Microbiology, held this week in New Orleans, showed that neckties worn by doctors were eight times more likely to harbor pathogens than those of hospital workers not normally in contact with patients. While working at New York Hospital in Queens, lead author Steven Nurkin, a medical student at the American-Technion Program at the Bruce Rappaport Facility of Medicine in Haifa, Israel, noticed that physicians' neckties often come into contact with patients or their bedding, reports Reuters. He and his colleagues swabbed 42 neckties worn by physicians who regularly saw patients and 10 neckties worn by security personnel. Twenty of the clinicians' neckties carried pathogens, including Staphylococcus aureus, Klebsiella pneumoniae, Pseudomonas aeruginosa, and Aspergillus. Only one security guard’s tie carried a single pathogen, S. aureus. To reduce the risk of disease transmission, Nurkin suggests switching to bow-ties; using tie tacks that hold ties to physicians' shirts; decontaminating ties with a “high quality detergent spray that wouldn't ruin the tie” or using a “necktie condom.” Nurkin's group is considering further studies with larger sample sizes to confirm their findings.

The General Accounting Office (GAO) has released the following report: Antibiotic Resistance: Federal Agencies Need to Better Focus Efforts to Address Risk to Humans from Antibiotic Use in Animals. Among GAO recommendations are that FDA expedite its risk assessments of drugs that are used in animals that are critical for human health; and USDA and HHS develop and implement a plan to collect data on antibiotic use in animals. The full report, GAO-04-490, is available at http://www.gao.gov/cgi-bin/getrpt?GAO-04-490. Highlights of the report can be found at http://www.gao.gov/highlights/d04490high.pdf

Interpore Cross International Inc. said on Tuesday a California court ruled that Medtronic Inc. infringed its patent over spinal screws used for implants. The United States District Court for the Central District of California still must rule on Medtronic's counter-claim that the patent is not valid, and other matters, before any remedies will be considered, Interpore Cross said. A motion to determine the issue of validity of the patent and Medtronic's other defenses is set for July 12.

Hayes, Inc. has released its report on carotid artery stenting (CAS) for the treatment of carotid artery stenosis. The HAYES report provides an in-depth assessment of CAS, which is being studied to see if it is effective in reducing blockage within a carotid artery and if it prevents further clogging. Criteria defining when and for whom carotid artery angioplasty with stenting should be recommended have not been established. However, there is good evidence that CAS is effective in treating patients who have symptoms of carotid artery atherosclerosis and severe clogging, or 50% to 70% blockage, of a carotid artery. No specific CAS system has received Food and Drug Administration approval to date. This report cautions that CAS is not recommended for patients with: clogging of a carotid artery that also involves a blood clot blocking blood flow; atherosclerosis within a carotid artery that cannot be reached with the catheter; or any condition that does not allow angiography to be performed. Additional information in the report includes safety issues, cost-effectiveness, analysis of unpublished data, and FDA approval status of other types of stents and embolic protection devices that are approved for other indications. A summary of the report is available at www.hayesinc.com/summary/carotid.

The Health Industry Group Purchasing Association (HIGPA) announces that all of its 28 American-based group purchasing organization (GPO) members have self-certified compliance with the Association’s GPO Code of Conduct Principles. The purpose of HIGPA’s Code of Conduct is to strengthen and improve the delivery of products and services to healthcare providers. HIGPA’s Code of Conduct is the only enforceable business ethic requirement for the healthcare industry; all other codes of conduct are on a volunteer basis. The Association’s Board of Directors and HIGPA’s membership made the Code of Conduct self-certification process a requirement for membership.

Michigan is getting $16 million to help hospitals take precautions against bioterrorism, natural disasters and infectious diseases. New Jersey will receive nearly $14 million in federal anti-terrorism funds. The federal grants announced by the federal Department of Health and Human Services are part of $498 million in nationwide funding. Recipients will be facilities expected to deal with large numbers of casualties during an attack. Grant recipients also will use the money to coordinate disease reporting among hospitals and health departments and to enhance coordination between hospital- and public health-based labs. Funds also can be used to provide trauma and burn care, to buy communications equipment and protective gear, and to provide behavioral health services. Among other grants announced, Minnesota will receive $8.5 million; Wisconsin will receive $9.1 million, Iowa will get $5.4 million and South Dakota, $2.1 million.

Join NAMSA on July 15 - 16 in Framingham, MA for Developments in Medical Device Testing. This seminar and workshop provides the most current information required by regulatory bodies for market approval of medical devices and component materials. Topics covered include Biocompatibility, Materials Characterization, Sterilization Methods, Program Design, and Packaging Validation. Anyone involved in the design, development, or manufacture of medical devices will benefit from attending. For more information or to register, contact Rachael Lanning at 419-662-4397 or visit us online at www.namsa.com

The United Nations' health agency agreed to launch a global campaign against obesity, blamed for an increase in deadly chronic diseases worldwide. The Global Strategy on Diet, Physical Activity and Health was backed by the policy committee of the World Health Organization's annual assembly. The plan recommends limiting intakes of fats, sugar and salt, blamed for a rise in cardiovascular disease, type 2 diabetes and some cancers. These chronic diseases account for nearly 60 percent of the 56.5 million deaths a year around the world that are considered preventable, according to the WHO. According to the World Heart Federation, 1.1 billion adults and 22 million children under age five are obese, worldwide.

Hill-Rom has a new pressure-relief mattress designed to help in the prevention and early treatment of pressure ulcers. The PrimeAire(R) ARS Pressure Relief Mattress features non-powered, air-based technology to provide performance superior to traditional foam mattresses. The mattress provides hospitals and long-term care facilities with many of the benefits of high-performance surfaces, at a lower cost. With several features designed to relieve pressure on the patient's skin, the PrimeAire(R) ARS Pressure Relief Mattress helps reduce the risk of pressure ulcers forming, particularly in sensitive areas such as the heel. Along with enhanced performance, the mattress is also engineered to improve safety and comfort. The mattress uses an Air Reflex(TM) system in which multi-chambered air cylinders gently expand and contract with patient movement, providing continually equalized pressure without the power source used to distribute pressure in high-end treatment surfaces.

Jefferson Regional Medical Center (JRMC), a not-for-profit public 470 bed hospital serving South Arkansas, has recently standardized on Masimo SET (Signal Extraction Technology) oximetry hospital-wide. JRMC cited improved monitoring during high motion and poor perfusion, and overall cost-savings, as key reasons for the conversion.

The Institute for Safe Medication Practices (ISMP), the nation’s only nonprofit organization devoted entirely to medication error prevention and safe medication use, is celebrating its 10th anniversary of incorporation this year. ISMP has successfully advocated for improvements in drug names, labeling and packaging, technology, and medication practices that have led or could lead to medication errors. One example is stopping the direct administration of lidocaine concentrate prefilled syringes. Each year, the national Medication Errors Reporting Program (MERP), now operated by the United States Pharmacopeia (USP) in cooperation with ISMP, receives nearly 1,000 error reports from healthcare professionals. During its year-long anniversary celebration, ISMP will hold regional and national celebration events, publishing a historical retrospective on its work, and giving lectures/presentations on the past and future of medication safety. For more information, visit www.ismp.org.

Consorta, Inc. will move its headquarters from its current suburban Chicago location in Rolling Meadows to Schaumburg, Ill., effective May 24. Consorta’s new address will be: Consorta, Inc., Schaumburg Corporate Center, 1475 East Woodfield Road, Suite 400, Schaumburg, IL 60173, 847-592-7800 phone, 847-592-7801fax. Consorta’s new headquarters will provide more room for operations, and will create additional space for the operations of Consorta Custom, which develops customized supply chain solutions for larger healthcare systems.

Legislation to encourage drug, vaccine and medical-device makers to develop countermeasures against bioterror attacks has passed the U.S. Senate. The $5.6 billion 10-year Project BioShield program creates incentives for research and helps guarantee a market for treatments, antidotes and vaccines that would otherwise not find a viable commercial niche. The government will use the funds to encourage research and to purchase and stockpile vaccines or treatments for potential bioterror agents such as smallpox, anthrax, botulism and ebola. The bill also will encourage more research in both the public and private sectors.

The Centers for Disease Control and Prevention awarded a total of $49 million to 142 community-based organizations for efforts to prevent HIV infections. The organizations will use the funds to implement HIV prevention interventions, counseling, voluntary HIV testing and referral services, and health education and risk reduction. Averaging $345,000 each, the awards support a CDC initiative launched last year to reduce new HIV infections. For more on the initiative, visit http://www.cdc.gov/hiv/dhap.htm.

Dr. Paul F. Wehrle, a pediatrician and researcher who helped diagnose and devise treatments for polio, smallpox and other infectious diseases, died May 11 in San Clemente, CA, at the age of 82. The cause was complications following a long illness, said a son, Dr. Malcolm Wehrle of La Canada, CA, reports the New York Times. In the 1950's, Paul Wehrle worked on clinical trials of the Salk polio vaccine. From 1961 to 1988 he was chairman of the department of pediatrics at the medical school of the University of Southern California. From 1969 to 1970, he took a year's leave from the university to join the World Health Organization's efforts in eradicating smallpox throughout the Third World. In that year, he conducted a study of an outbreak of smallpox in a German hospital that helped establish that virus particles of the disease could be carried through the air to infect other people, reported the Times.

Care Fusion announced an agreement with Central Michigan Community Hospital (CMCH) to provide barcode technology solutions to be implemented throughout the hospital. CMCH contracted with Care Fusion for a comprehensive suite of products including: wCareMed™ to support medication administration, allergy warnings, safety alerts and complex IVs; wCareCollect™ to verify and label lab specimens; wCareAssist™ to record vital signs and patient care information; wCareView™ for a consolidated view of patient data; and wCareCapture™ for point-of-care billing for supplies and inventory control.

Misys Healthcare Systems announced that it has signed an agreement with Pascack Valley Hospital in Westwood, N.J., to purchase Misys Optimum clinical information management solutions including Misys CPR, Misys Data Warehouse, Misys Media Manager, Misys Laboratory and Misys Encompass. Pascack Valley Hospital will employ the Misys CPR fully integrated computer-based patient record information system with CPOE in order to improve quality of care and patient safety including medication error reduction.

Consorta has selected Freedom Medical, Exton, PA, as one of its providers of medical equipment rental services. The available equipment includes a variety of monitors, pumps and other devices for patient care in acute or long-term care settings. Freedom currently has 17 rental locations and is rapidly expanding.

Cardinal Health Inc. has agreed to acquire Alaris Medical Systems for $1.6 billion to expand its line of medication safety products and its geographic reach, the companies said on Wednesday. Under the deal, expected to close by June 30, Cardinal will make a cash tender offer to buy all outstanding Alaris common stock for $22.35 per share. Including Alaris debt being assumed by Cardinal, the deal is worth $2 billion, the companies said. Alaris develops and markets systems for the safe delivery of intravenous (IV) medications, and holds long-term contracts to provide necessary, disposable products for use in those systems. It also provides a suite of professional, technical and training services to more than 5,000 hospitals and healthcare systems worldwide. In 2003, Alaris launched 19 new products into this market and expects to launch at least 20 more in 2004. Alaris’ bedside safety offerings in IV medication and infusion therapy complement Cardinal Health’s medication safety offerings at the patient’s bedside. The Alaris Medical Systems Medley™ Medication Safety System is a modular point-of-care computer that integrates infusion, patient monitoring and clinical best practice guidelines in a single platform. Upon completion of the acquisition, David L. Schlotterbeck president and chief executive officer of Alaris Medical Systems will continue to lead Alaris operations, reporting to Cardinal Health President and Chief Operating Officer George L. Fotiades; Alaris will become a wholly owned subsidiary of Cardinal Health.

Doctors at the Medical College of Pennsylvania, a Tenet Healthcare Corp. hospital scheduled to close June 30, are proposing to keep the facility open as a not-for-profit institution, said Pennsylvania officials. A spokeswoman for Gov. Edward Rendell said that funding from benefactors to keep the hospital open has already reached $10 million, and could triple. According to Reuters News Service, a cardiologist who heads the Association to Save MCP said her group is raising an additional $45 million from healthcare financing companies. The Association to Save MCP sued Tenet to prevent the hospital from closing in March, keeping the hospital open through June.

Under proposed new Food and Drug Administration regulations, virtually all donated tissues and cells, including sperm and stem cells, must be screened for diseases from syphilis to SARS. Since 1993, the Food and Drug Administration has required that muscles, tendons, skin and eye tissue donations be tested for hepatitis B and C and for the AIDS virus. The new rule regulates reproductive tissue, hematopoietic stem cells derived from cord blood and peripheral blood sources, cellular therapies and other innovative products. The new rule also extends the scope of protection against communicable diseases that can be transmitted through transplanted tissues and cells, including Creutzfeldt-Jakob disease, syphilis and, for relevant tissues, human T-cell lymphotropic virus, and the bacteria that cause chlamydia and gonorrhea. The rule, which is open for comment, would also give FDA the option of imposing screening requirements for emerging new infections such as West Nile virus and Severe Acute Respiratory Syndrome. The rule, effective May 25, 2005, is available at www.fda.gov/cber/rules/suitdonor.pdf.

In an effort to control costs, the California Public Employees' Retirement System (CalPERS) board voted 10-1 yesterday to exclude 38 hospitals from its largest HMO network. The California Healthcare Association said that patient demand, the rising number of uninsured, state mandated staffing ratios and seismic safety regulations were more to blame for rising costs. Among the excluded hospitals are Cedars Sinai Medical Center in Los Angeles, hospitals in San Diego's Sharp HealthCare system, Northern California's Sutter Health hospitals, and Orange County's Hoag Memorial Hospital.

The House voted 331-88 on Tuesday against a bill that would have required emergency department physicians to report undocumented immigrants that they treat and deny most types of emergency care to them. The legislation, sponsored by Rep. Dana Rohrabacher (R-CA), would require hospitals that accept federal funds to treat undocumented immigrants, to ask patients whether they are U.S. citizens. Hospitals would have to report to the Department of Homeland Security the immigration status, address and employer of a patient who is not a U.S. citizen.

Walgreens announced a new health education program to help consumers find health services and discounts, with a focus on the new Medicare discount cards. The education campaign is designed to reach consumers in stores, online and in the community. Currently, Walgreens is working with the American Library Association and U.S. Health and Human Services to provide Centers for Medicare and Medicaid Services (CMS) educational materials on the new Medicare discount cards to consumers at all of the nation’s 16,400 libraries. Other Walgreen information initiatives include training pharmacists to address current issues, offering health information online at www.walgreens.com through an arrangement with Mayo Clinic Health Information, and providing prescription labels in 14 different languages.

Bristol-Myers Squibb, Gilead Sciences Inc. and Merck & Co. Inc. said they are discussing the development of a combination of three anti-HIV drugs, after U.S. officials urged drug companies to provide better treatment options in developing countries. The companies said the once-daily, fixed-dose combination would include Viread and Emtriva, both Gilead drugs. It would also include efavirenz, marketed in the U.S., Canada and certain European countries by Bristol-Myers as Sustiva, and elsewhere by Merck as Stocrin. Secretary of Health and Human Services Tommy Thompson has announced an expedited approval process for the combination drugs. Gilead, Merck and Bristol-Myers said they are also considering certain co-packaging options for the individual products. GlaxoSmithKline Plc and Germany's Boehringer Ingelheim also said they are in talks to assess co-packaging of anti-retroviral drugs for the treatment of HIV.

This week, a subcommittee of the California State Legislature is expected to approve Senate Bill 1336. If enacted, the bill would make it legal for dentists with training in oral surgery to perform cosmetic surgery on the face. “The whole thing is so audacious that I have trouble controlling myself,” said Dr. Harvey A. Zarem, the president of the California Society of Plastic Surgeons. If the bill is approved it will be up for approval as a law later this year by Gov. Arnold Schwarzenegger. There are about 6,600 plastic surgeons certified by the American Board of Plastic Surgery; most estimates suggest that there are three to four times that number of practitioners performing cosmetic surgery without board certification. The dentists seeking the new privileges are oral and maxillofacial surgeons. The oral surgeons argue that because of their training repairing bones and structures of the jaw and face, they should be allowed to perform the procedures that physicians do, said Dr. P. Thomas Hiser, president of the California Association of Oral and Maxillofacial Surgeons.

Scientists have identified another gene which increases a woman's risk of developing breast cancer. An international study of 20,000 women found having a faulty version of the CHEK2 gene doubles their cancer risk. The American Journal of Human Genetics study said the findings could help aid in the development of a comprehensive genetic test of breast cancer risk. Two other faulty genes, BRCA1 and BRCA 2, which increase a woman's breast cancer risk by between 50 and 80%, were identified in the mid-1990s. A mutated version of CHEK2 would not allow shutdown of faulty cells so they can be repaired, meaning faults in other genes are more likely to evade the body’s repair process and continue replicating. The variant was found in 201 women with breast cancer and 64 healthy women. From these figures, the researchers suggest having the faulty variant more than doubles a woman's risk of developing breast cancer, whether or not there is a history of the disease in the family.

CryoLife receives FDA approval of new
delivery system for surgical adhesive

CryoLife, Inc., a human tissue processing and surgical device company, today announced the FDA approval of a new disposable delivery system for BioGlue Surgical Adhesive. The new BioGlue Syringe is expected to provide clinicians with improved convenience and ease of use. The BioGlue Syringe provides surgeons with an effective adhesive in an easier-to-use, self-contained, disposable syringe. The BioGlue Syringe will be available in 2ml and 5ml volumes. BioGlue is a two-component adhesive that creates a flexible, mechanical seal, independent of the body's clotting mechanism, within 20 to 30 seconds and reaches its maximum bonding strength in two to three minutes. The Company's BioGlue Surgical Adhesive is FDA approved as an adjunct to sutures and staples for use in adult patients in open surgical repair of large vessels.

Overall hospital prices rose 0.4% in April, and were 5.2% higher than a year ago, reports the Bureau of Labor Statistics. Prices at general medical and surgical hospitals rose 0.5% and were 5.3% higher than in April 2003, according to the BLS' Producer Price Indices, which measure average changes in selling prices received by domestic producers for their output. For hospitals, this translates into actual or expected reimbursement for a sample of treatments or services. The PPI for hospitals measure changes in actual or expected reimbursement received for services across the full range of payer types. This includes the negotiated contract rate from the payer plus any portion expected to be paid by the patient. For more, go to http://www.bls.gov/ppi/.

Kentucky's first bird with West Nile virus this year has been discovered in Ohio County. A mourning dove found earlier this month at Beaver Dam tested positive for the virus, which can be transmitted by mosquitoes to birds, horses and humans. The Green River District Health Department in Owensboro said the unusually warm spring encouraged mosquito breeding. Officials say they'll try to eliminate the mosquitoes by treating areas of standing water and spraying mosquito repellent. While milder cases of the virus cause flulike symptoms in humans, West Nile can lead to potentially fatal encephalitis. The state Department of Public Health reported 14 human cases of West Nile in 2003, with one death. The virus was also found in 102 horses and 111 birds last year.

Researchers report that companies can save millions in healthcare costs by encouraging their employees to exercise a few times a week. They said that while obese employees have higher healthcare costs, by exercising a few days a week they can lower those expenses even without weight loss. Feifei Wang and colleagues at the University of Michigan studied 23,500 workers at General Motors. They estimated that getting the most sedentary obese workers to exercise would have saved about $790,000 a year, about 1.5 percent of healthcare costs for the group. Company-wide, the potential savings could reach $7.1 million per year, they reported in the Journal of Occupational and Environmental Medicine. Of the whole group of workers, about 30 percent were of normal weight, 45 percent were overweight, and 25 percent were obese. Annual healthcare costs averaged $2,200 for normal weight, $2,400 for the overweight, and $2,700 for obese employees. But among workers who did not exercise, healthcare costs went up by at least $100 a year, and were $3,000 a year for obese employees who were sedentary. But adding 20 minutes of light exercise two or more days a week lowered costs by on average $500 per employee a year.

Radiologists can now use their laptops to drive high resolution medical display monitors with uncompromised diagnostic quality images. Quest International, an Authorized Master Distributor for Totoku Medical LCD Monitors, has designed the Medical Docking Station (MDS) which permits a laptop computer to drive one or two external monitors up to 5 Megapixels. With a set of monitors at home and a set at the hospital or imaging center, a doctor may move freely between locations, carrying only a laptop and the MDS. The MDS interfaces with the internal PCI bus of the laptop computer via the Type II PCMCIA slot. The 32-bit PCI bus is then able to drive a high-resolution video card that is included in the MDS at the full 132MB/sec bandwidth of the PCI bus. Three models of the docking station are available, the MDS-2, MDS-3, and the MDS-5 for driving a pair of 2 megapixel, 3 megapixel and 5 megapixel LCD monitors respectively.

St. Jude Medical, Inc. announced approval by the U.S. Food and Drug Administration (FDA) of the Frontier(TM) biventricular stimulation device (model 5508L) and Aescula(TM) left-ventricular lead, designed to improve cardiac functional capacity in patients with chronic atrial fibrillation undergoing AV nodal ablation. Approximately 37,000 AV nodal ablation (ablate and pace) procedures were performed in the U.S. during 2003. Health Research International projects an annual 18% increase in cases for each of the next five years. The procedure is usually recommended when rapid, unsynchronized atrial heart rhythms cannot be managed pharmacologically. The St. Jude Medical Frontier(TM) biventricular pacing system consists of the Frontier(TM) biventricular pacing device and the Aescula(TM) left-ventricular lead, which has been engineered to resist dislodgement while optimizing capture and sensing thresholds.

Minnesota Gov. Tim Pawlenty announced a new program that will allow state employees to obtain certain prescription drugs for free if they order the medication from a state-inspected Canadian pharmacy. The program applies to 45 of the most popular name-brand medicines that do not have generic alternatives. State officials estimate savings of $1.4 million a year because the drugs can be purchased for less in Canada. About 120,000 employees and their dependents would be eligible. The state would cover shipping fees, along with the $15 monthly co-payments that are required for each prescription if employees buy their medicines from U.S. pharmacists. The governor cautioned that the program carries risks, explaining he hoped it would not invite a government crackdown on drug imports.

People who set aside salary in tax-free accounts for health bills could shift unused funds into the next year or long-term health savings accounts under legislation approved Wednesday by the House. The legislation, approved 273-153, is one of three measures that Republicans are pushing during a week of increased focus on healthcare and the uninsured. The bill would allow up to $500 left over at the end of one year to be used for health care expenses in the next year or invested in the health savings accounts that were created in last year's Medicare law.

Biophan Technologies, Inc., a leading developer of next generation biomedical technology, announced that it has acquired a majority interest in TE-Bio, LLC, a company developing a long-life power source for use in implanted medical devices, such as pacemakers, defibrillators, neurostimulators, and drug pumps. The technology is based on a patented innovation in the utilization of thermoelectric materials, using nanoscale-based, thin-film materials to convert thermal energy produced naturally by the human body into electrical energy. The resulting power can be used to "trickle charge" batteries for medium-power devices such as defibrillators, or directly power low-energy devices like pacemakers. TE-Bio is developing an implantable power system that has the potential to provide as much as a 30-year life, a five-fold increase in service life compared to existing technology. The technology is anticipated to extend the service life of neurostimulators and drug pumps that are used for treatment of tremors, diabetes, and chronic pain. Since these devices can be implanted in young patients, the combination of TE-Bio technology and extended device life may reduce the number of replacement implants needed throughout a patient's life.

AmerisourceBergen has developed a pharmacy-based medication packaging system that can reduce med-pass time by up to 50 percent and improve overall facility efficiency. The AutoMed Technology compliance packaging system dispenses patient medication in continuous strips of individual unit-dose or multi-dose packets. The flexible, easy-tear packets are tamper-proof, can be labeled with a barcode, and contain oral solid medications in the correct dose, sequenced by administration time. Packets are collated by the time of day and patient, so caregivers only pull doses needed for the immediate medication pass, eliminating the need to stage the next dose or rotate medications and saving time. The unique packaging solution eliminates the need for bulky cassettes or hard-to-open blister packs as well as any manual filling or labeling. Optional barcoding allows bedside verification, which can help reduce errors associated with improper dosing and/or drug administration. When utilizing the AutoMed compliance packaging system, administration cycles are virtually unlimited, from a cycle as short as 24 hours to 90 days or longer.

Lockheed Martin has won a $47.8 million contract to develop and integrate software applications for the Department of Defense's Theater Medical Information Program (TMIP), Block 2. The program calls for the interoperability and integration of data from several existing DoD Military Health System medical applications so that standard electronic medical records can be generated and maintained in theater under a variety of conditions. These records must then be transportable electronically or manually with a military patient to central DoD healthcare facilities. The data are also consolidated and made available to commanders in near real time through the Global Combat Support System (GCSS).

Canadian authorities have discovered a new case of bird flu in a duck and goose farm in western Canada, but health officials said it is probably not the strain that has killed 24 people in Asia. “Preliminary serology tests have found an H5 virus,” Canadian Food Inspection Agency (CFIA) spokesman Marc Richard said, but he added that it is too soon to say whether it is the deadly H5N1 strain found in Asia.

South Carolina's state Department of Health and Environmental Control might put a moratorium on the building and expanding of ASCs for at least a year, according to published reports. A provision slated to be included in a draft of the 2004 state health plan will be introduced to state Health Planning Committee June 3. State law requires that the health plan be updated at least every two years. Since 2001, the state health plan has mandated that, before approval could be granted for a new ASC, all existing ASCs in a county had to be licensed and operating for one year to determine the utilization levels for those ASCs. “Our state association met last week to plan a strategy to challenge the moratorium when it goes to public hearings,” says Jo-Ann Pinel, RN, CPN(C), the director of nursing at Palmetto Surgery Center in Columbia, S.C., and a SCASCA officer. “We are seriously considering hiring a lobbyist. I now truly believe this is the first step in an attack on the viability of ASCs.”

IntelliCare, a provider of medical contact center services and technology, announces that Ellen Curran, RNC, CEN has been named the 2004 Telenurse of the Year, and that Beth Roehm, RN has been named finalist. IntelliCare launched the Telenurse of the Year award this year to recognize outstanding achievement in the rapidly growing field of telenursing. “Because our nurses deliver care via the phone, they develop a unique set of skills for assessing and building relationships with patients,” says Victor C. Otley III, CEO of IntelliCare. The Telenurse of the Year award is open to nurses employed by IntelliCare or by the company's software clients. A panel of industry experts evaluated the nurses' contributions in three areas: improving the patient experience; contributing to the advancement of the telenursing profession; and pursuing professional growth as a telenurse. Ellen Curran, an IntelliCare employee, has been a practicing nurse since 1978. She has extensive experience in emergency medicine and case management and became a telenurse in 1993. Beth Roehm, RN, of St. Louis Children's Hospital in St. Louis, MO, has been a nurse for 25 years, and has been a telenurse for nearly five years.

St. Jude Medical, Inc. announced the global launch of the Apeel(TM) CS Catheter Delivery System and U.S. Food and Drug Administration (FDA) 510(k) clearance of the Reflexion Cannulator(TM) Catheter with Lumen. These tools are designed to enable faster, easier placement of the left-ventricular (LV) lead for cardiac resynchronization therapy (CRT) and biventricular pacing procedures. The St. Jude Medical Apeel(TM) CS Catheter Delivery System offers design features that help physicians during the LV lead implant procedure; from a selection of curves to handle varying patient anatomies, to the ability to remove the sheath without the need for cutting tools. For patients whose cardiac anatomy creates an unusual challenge, the St. Jude Medical Reflexion Cannulator(TM) Catheter with Lumen gives physicians an additional tool to aid LV lead placement. This catheter provides both steerability for added control and a lumen that will accommodate guidewires or contrast injection, helping users visualize and access targeted areas in their patients' hearts.

In recognition of National Alcohol Awareness Month in May, Good Samaritan Hospital in Suffern, NY has developed a series of programs and seminars focused on education and treatment. Many of the programs will focus on the special needs of people over the age of 60. According to the U.S. Department of Health and Human Services, more than one-half of American adults have a close family member who has or has had alcohol-related problems. Recent statistics have indicated that approximately three million people over the age of 60 have a problem with alcohol and do not give the disease the attention it needs. It has been shown that alcohol is responsible for more than 70 percent of hospital admissions and hospitalizes more people in this age group than heart attacks. Throughout the month, Good Samaritan will be offering informal screenings for alcohol abuse and dependency, as well as information and education about the disease of alcoholism.

Pfizer, the world's largest pharmaceutical company, pleaded guilty yesterday and agreed to pay $430 million to resolve criminal and civil charges that it paid doctors to prescribe its epilepsy drug, Neurontin, to patients with conditions that the drug was not federally approved to treat. Of that settlement, $26.64 million will go to a former company adviser who brought a lawsuit under a federal "whistleblower" law. The company encouraged doctors to use Neurontin in patients with bipolar disorder, even though a study had shown that the medicine was no better than a placebo in treating the disorder. Other disorders for which the company illegally promoted Neurontin included Lou Gehrig's disease, attention deficit disorder, restless leg syndrome and drug and alcohol withdrawal seizures. Nearly 90 percent of the drug's sales continue to be for ailments for which the drug is not an approved treatment, according to recent surveys. Pfizer, in a statement yesterday, said that the illegal marketing had been conducted by Warner-Lambert before Pfizer acquired that company in 2000.

Fujisawa Pharmaceuticals ran an advertisement failing to warn consumers that its drug to treat transplantation complications posed risks of infection and malignant tumors, U.S. regulators said in a letter Thursday. The Food and Drug Administration said a January ad placed in two medical journals by the Japanese drug maker's U.S. division, Fujisawa Healthcare, did not note important side effects of its drug Prograf. Prograf suppresses the immune system to prevent organ rejection in transplant patients. Possible problems include an increased susceptibility to infection and malignant tumors in lymphatic tissues or lymphoma. The letter is available at http://www.fda.gov/cder/warn/2004/12327Prograf.pdf.

President Bush has named his acting AIDS adviser, Carol J. Thompson, as head of the Office of National AIDS Policy. Thompson has held the post on an interim basis since August. Before that, she was a White House domestic policy adviser and worked at the Department of Health and Human Services and the Office of the U.S. Trade Representative. She replaced Joseph O'Neill, whom Bush had named deputy coordinator of a new office that coordinates response to the global AIDS pandemic. Thompson helped to enact and implement Bush's five-year, $15 billion plan aimed at stopping the spread of HIV/AIDS worldwide.

Florida hospital installs new mammography software

Sarasota Memorial Hospital (Sarasota, FL) is one of the first facilities in the U.S. to install a new mammography software upgrade that enables its KODAK DRYVIEW 8900 Laser Imaging System to print radiographic film images from full-field digital mammography (FFDM) systems. With the new software, Sarasota Memorial's 8900 imager can print images from its two FFDM systems with up to 3.6 D-max on both 8x10” and 10x12” KODAK DRYVIEW Mammography Laser Imaging Film. The imager also prints radiographic film images from MR, CT, CR, ultrasound and other digital medical imaging modalities. Prior to the mammography upgrade, the hospital used the KODAK DRYVIEW 8610 system for digital mammography output. The 8900 system's mammography upgrade provides test patterns that can be printed on demand to aid in the stringent quality control required by accreditation and regulatory agencies.

The American Vascular Association announced it is offering free vascular disease screenings to thousands of Americans around the country in an effort to educate the public about vascular disease detection and prevention. The free screenings will take place on the third annual National Screening Day, held this year on May 14. More than 10,000 Americans die each year of vascular disease-related afflictions; strokes due to carotid artery disease are the number one cause of disability in this country and the third-leading cause of death; and rupture of abdominal aortic aneurysms (AAAs) is the tenth-leading cause of death in men over 50. The tests will include a carotid duplex ultrasound scan for carotid artery disease, an ultrasound aortic scan for abdominal aortic aneurysms, and a Doppler test for peripheral arterial disease (PAD). Participants also will have their blood pressure measured and their heart rhythm recorded.

The World Health Organization said in its annual report that AIDS was the leading single cause of death worldwide for people ages 15 to 59. In 2003, three million people died of AIDS and five million people were infected with H.I.V., the agency reported. Lee Jong Wook, the director general of the W.H.O., called for a dramatic increase in the supply of antiretroviral drugs to treat H.I.V. He said in the report, which is to be presented next week in Geneva, that less than 7 percent of the six million people with H.I.V. in developing countries were thought to have access to treatment. Lee said the agency set a goal to distribute antiretroviral drugs to three million H.I.V. patients in sub-Saharan Africa by the end of 2005.

As reported by New York’s News 10 Now, a woman diagnosed with Creutzfeldt-Jakob Disease (CJD), a rare disease similar to Mad Cow, has died. No one is sure how Cindy Hildreth of Central Square contracted CJD, but hospital officials say the illness can take twenty years to appear after exposure. University Hospital administrators reported a confirmed case of the disease to state and local health officials last month. The hospital maintains there is no risk to hospital employees or the public. CJD, as it is known, can only be acquired through exposure to central nervous system tissue. CJD affects about one in every million people.

A decade-long study comparing conventional colon cancer surgery with laparoscopic surgery found identical success rates. The biggest comparison of the two procedures to date, involving 48 hospitals in the U.S. and Canada, found the same rates of survival, tumor recurrence and surgical complications. In addition, patients who had laparoscopic surgery had less pain and less time in the hospital. Experts predicted that the results would end the virtual moratorium on such surgery that began in 1994 because of spotty evidence that tumors returned in up to 21 percent of patients getting laparoscopic procedures, much more frequently than with open surgery. The study was financed by the National Cancer Institute and published in the current issue of The New England Journal of Medicine. The study involved 872 patients. Half were randomly chosen for the laparoscopic procedure, while the rest got open surgery, with strikingly similar results. Complications, like wound infections and bleeding, occurred in 21 percent getting laparoscopy and 20 percent getting open surgery, while 86 percent of patients getting the laparoscopic procedure and 85 percent getting open surgery were alive three years later. Cancer returned in 16 percent of patients getting laparoscopy versus 18 percent getting open surgery.

RITA Medical Systems, Inc. ("RITA") and Horizon Medical Products, Inc. ("Horizon") signed an agreement to merge the two companies, combining their respective strengths in the development, manufacture and marketing of medical oncology devices for the treatment of cancer. Mr. Joseph DeVivo, President and CEO of RITA, will serve as President and CEO of the combined company, and Mr. Robert J. Wenzel, Chief Operating Officer and interim CEO of Horizon, will serve as Chief Operating Officer. The Board of Directors will be composed of six members of the current RITA Board of Directors, including Joseph DeVivo, and three members of Horizon's current Board of Directors. The chairman of the Board of Directors of the combined company will be Mr. Vin Bucci, current Chairman of the Board of RITA. The company will be headquartered in Mountain View, CA, with operations in Mountain View, CA, and Manchester, GA.

Samaritan Pharmaceuticals Inc. announced that Georgetown University has granted two exclusive worldwide licenses to Samaritan, to develop and market, Samaritan Research Lab's, HIV investigational drug candidates, for the treatment of HIV drug resistance. With an ongoing concentrated effort, to advance Samaritan's lead HIV drug SP-01A through the FDA, Samaritan realistically plans to focus on the preclinical trials, necessary to file an IND with the U.S. Food and Drug Administration, upon the FDA advancing SP-01A. Under the collaboration agreement, Georgetown University grants exclusive rights to develop manufacture and commercialize the licensed drugs for the treatment of HIV drug resistance, in exchange for royalties and payments, if the drugs are partnered, and or, commercialized by Samaritan.

The Association for Professionals in Infection Control and Epidemiology (APIC) announced that Julie Louise Gerberding, MD, MPH, Director of the Centers for Disease Control and Prevention (CDC) will be the keynote speaker at APIC’s June national convention in Phoenix, AZ. Gerberding is also Administrator of the Agency for Toxic Substances and Disease Registry (ATSDR) and Associate Clinical Professor of Medicine (infectious diseases) both at Emory University and the University of California in San Francisco. Prior to becoming CDC’s Director, Dr. Gerberding was Acting Deputy Director of the National Center for Infectious Diseases (NCID), at CDC, where she played a major role in leading the agency’s response to the anthrax bioterrorism events of 2001. She also addressed the challenges at the onset of the AIDS epidemic in San Francisco, by providing care to infected patients and helped facilitate HIV transmission prevention research. Dr. Gerberding initiated the model for an HIV post-exposure hotline to provide immediate assessment and treatment for healthcare workers exposed to HIV via needle stick injuries. She will address the issues of patient safety and the role of infection control in her address. Dr. Gerberding is a member of the Society for Healthcare Epidemiology of America (SHEA) and is serving her second year as Academic Counselor on the Board of SHEA.

The Institute for Safe Medication Practices (ISMP), in partnership with the Health Research and Educational Trust (HRET) and the American Hospital Association (AHA), has launched the 2004 ISMP Medication Safety Self Assessment for hospitals. The assessment is being distributed to hospitals across the country; and ISMP estimates that the preliminary aggregate national data will be released in late 2004. The 2004 assessment will help participating hospitals measure their progress in medication safety since the last survey in 2000, and allow all hospitals to compare their current systems and practices to other demographically similar hospitals nationwide. The 2004 ISMP Medication Safety Self Assessment will also assist in the development of educational tools and training materials to further enhance safe medication administration. For more information and for a list of the endorsing organizations, visit www.ismp.org

Analysts say that Johnson & Johnson (JNJ), after introducing a drug-coated stent nearly a year before competitors in the U.S., has already lost its lead. At the same time, The Boston Scientific Corporation, which introduced a rival drug-coated stent two months ago, said it had captured about 70 percent of new orders, reports the New York Times. Many doctors say they prefer the stent made by Boston Scientific, called Taxus, to the one made by JNJ, called Cypher. Given what they describe as largely equivalent results from the drugs coating the stents, they say Taxus is much easier to use than Cypher, reports the Times. After JNJ introduced the first stent in 1994, rival Guidant, quickly overtook the market. Many doctors were upset over how much JNJ charged for its stent and what they saw as the company's failure to innovate. JNJ’s sales were hurt early on with this new stent mainly due to the company’s inability to make enough of them early on. When regulators asked JNJ to make changes in the stent before approving it for the U.S. market in April 2003, the company was forced to throw away much of its original inventory. As a result, after Cypher came to market, doctors who wanted the stents could not get them.

Thoratec says bill would expand Medicare
coverage of heart pump

Proposed Medicare rules would add 30 percent to coverage for Thoratec Corp.'s heart pumps used on a permanent basis by end-stage heart failure patients, said the company. Thoratec said the proposed rules would reimburse the company's heart pumps at about $125,000 per procedure, compared with about $96,000 currently, when used as a permanent treatment. The CA-based company said some medical centers would qualify for much more generous reimbursement from the Centers for Medicare and Medicaid Services. The changes affect any ventricular assist device used to prolong life in heart failure patients too sick to receive a heart transplant. The changes would not affect coverage of the devices when used as a temporary treatment until a patient can receive a heart transplant. Thoratec said the proposed ruling is subject to a 60-day public comment period. The final rule is due Aug. 1, and would take effect Oct. 1. The company said it believes most of the patients who receive its heart assist devices for permanent use will be enrolled in Medicare.

Study shows vaccine has cut difference in
pneumonia infection rates among blacks

A childhood vaccine approved in 2000 for use in the U.S. has begun to ease a racial disparity in which blacks were more likely to be infected by pneumonia and meningitis, said a recent report from the Centers for Disease Control. Incidence of infections among U.S. black children under the age of two, fell from being 3.3 times higher than among white children before the vaccine, to 1.6 times higher in 2002. Between 1998 and 2002, annual U.S. incidence rates for invasive pneumococcal disease decreased from 19 to 12.1 cases per 100,000 among whites and from 54.9 to 26.5 among blacks. Published in this week's Journal of the American Medical Association, the report expressed concern that the vaccine, Prevnar, has been in short supply. Wyeth is the sole manufacturer of the vaccine, which protects against several different strains of pneumococcal bacteria. Supply problems have continued; the government earlier this year told doctors to temporarily cut back the vaccination schedule to two shots instead of four.

Consorta signs agreement with Medline
for durable medical equipment

Consorta, Inc. and Medline Industries, Inc. have signed a three-year agreement in which Medline will provide durable medical equipment at a savings to Consorta’s membership. The agreement features Medline’s line of durable medical products, including wheelchairs, walkers, canes and bathroom safety products.

The National Council of La Raza, a non-profit organization representing the interests of Hispanic Americans, joined representatives from the AHA, National Association of Public Hospitals and Health Systems, and Service Employees International Union in expressing opposition to the Medicare Modernization Act. H.R. 3722, sponsored by Rep. Dana Rohrabacher, (R-CA). The bill, which could go to the House floor as soon as next week, would require hospitals to identify and report undocumented immigrants to federal agencies to qualify for special funding. It would require hospitals to demand and upload personal data from such patients to a federal database for deportation purposes, and to retain such documents and data for at least five years. In addition to imposing new regulatory burdens on hospitals, the organizations said the measure would deter immigrants from getting the healthcare they need for fear of being reported to authorities, thus potentially posing a significant public health risk.

The incidence of Lyme disease jumped 40% from 2001 to 2002, reaching an all-time high of 23,763 cases, reports federal health authorities. Lyme disease has been increasing since reporting began in 1991 as people move closer to deer tick habitats and the range of the ticks has grown. The tick-borne disease was reported in every state except Hawaii, Oklahoma and Montana in 2002, the CDC says. The highest incidence of Lyme disease, accounting for 95% of cases, occurred in Eastern states from Maine to Maryland and in Wisconsin and Minnesota. In 2001, 17,029 cases were reported, an incidence of six cases per 100,000 people nationally. A year later, that had increased to 8.2 per 100,000. Preliminary figures on cases at the end of 2003 "were nearly identical" to 2002 numbers. A vaccine against Lyme disease was withdrawn from the market in 2002 by its manufacturer, which cited poor sales. Prevention through insect repellant and daily tick checks is the best way to guard against the disease.

ZOLL Medical Corporation, a manufacturer of non-invasive cardiac resuscitation devices, will unveil CodeNet(TM), the first software system that allows hospital teams to better document, manage, and review cardiac arrest event and resuscitation information. CodeNet brings new improvements and efficiencies in data capture, event time synchronization, and case and aggregate reporting. It is the only system that time stamps logged events and synchronizes these times with defibrillator data, providing clinicians with a complete and accurate timeline of an entire cardiac arrest event. CodeNet consists of two software applications: CodeNet Writer(TM), which is installed on a Pocket PC-based PDA and used to log code events, and CodeNet Central(TM), which is a database management system on a desktop or laptop computer.

St. Jude Medical, Inc. announced U.S. Food and Drug Administration (FDA) approval of the Riata® i lead family, currently the thinnest integrated bipolar implantable cardioverter defibrillator (ICD) leads. The isodiametric body diameter of Riata® i leads measures 2.2 mm or 2.5 mm (depending on model), and fits an 8 French introducer. The lead provides good helix visibility, handling and ease of implant. These new leads complement the full line of Riata® true bipolar leads already on the market. The new lead family allows physicians more versatility when managing patients with high defibrillation thresholds (DFTs).

Nearly 2,000 events are planned across the nation this week for the second annual Cover the Uninsured Week. Coordinated by the Robert Wood Johnson Foundation with support from a broad coalition of business, labor, healthcare and other organizations, including the AHA, the week focuses national attention on the need for stable, affordable health insurance for all Americans, including the nation's nearly 44 million uninsured. Events include health fairs and efforts to enroll eligible people in public health insurance programs.

Treatment with cholesterol-lowering medications may reduce the risk of death from a cardiac complication following major non-cardiac surgery, according to a study in the latest Journal of the American Medical Association. An estimated one million patients experience a heart attack or other cardiac complication following surgery, resulting in longer hospital stays and mortality rates as high as 40%. Using data from 780,591 adult patients who underwent major non-cardiac surgery in 2000, the study found a lower mortality rate for the nearly 10% of patients who received lipid-lowering therapy within the first two days of hospitalization; 2.13% compared with 3.05% for other patients. The study's lead author said clinical trials are needed to confirm the results of the observational study and determine the optimal timing and duration of lipid-lowering therapy. The study was based on data from 329 U.S. hospitals using the Perspective database, a quality and benchmarking tool developed by Premier Inc.

The Department of Veterans Affairs has announced that it will close three hospitals in Pittsburgh, PA; Brecksville, OH; and Gulfport, MI; and will build two new ones in Orlando, FL and Las Vegas, NV. The agency also will add or remove medical services at dozens of other facilities. Announced by VA Secretary Anthony J. Principi at a Las Vegas news conference, the restructuring is intended to streamline operations. The plan has been criticized by the General Accounting Office as wasting more than $1 million a day on unused or unneeded facilities. The plan concludes a process known as Capital Asset Realignment for Enhanced Services, which began in 2002. The changes, expected to cost more than $6 billion, will shift services to areas with growing veteran populations in the South and West. None of the hospitals will close before 2007, Principi said in an interview. Principi also has endorsed building 156 community-based outpatient clinics by 2012, with an emphasis on serving rural areas. The department also will create new spinal cord centers, in Denver; Minneapolis; Syracuse, N.Y.; and a still-undetermined city.

New strategic consulting company to address
hospital expense control and management

Strategic Initiatives In Healthcare, LLC, a new multifaceted healthcare consulting company, debuts to address the growing interest of healthcare chief executive officers, financial and operational executives in expense control and management. Headquartered in Seattle, WA, Strategic Initiatives In Healthcare, LLC, was conceived by William McFaul and Paul Ramey. McFaul co-founded McFaul & Lyons Inc., which specialized in the identification and implementation of non-labor expense reductions for hospitals and healthcare systems. McFaul sold to Johnson & Johnson in 1997. Paul Ramey has served as president of Hospital Shared Services, a hospital group purchasing company; and founded Institutional Purchasing Service (IPS). He was a founder and past president of the Health Industry Group Purchasing Association. Joe Colonna is to serve as president and CEO of Strategic Initiatives In Healthcare, LLC. Colonna was most recently Senior Vice President of NCI, a FL-based healthcare firm specializing in knowledge transfer, business transformation and performance optimization. Strategic Initiatives in Healthcare, LLC will focus on the “big picture” of ongoing processes for expense control and management in an environment of lower payer reimbursement, tighter regulatory scrutiny and growing competition from a variety of market players.

Kaiser Permanente has confirmed that the expected savings and financial outcomes from outsourcing its national contracting for medical/surgical and business products to Broadlane three years ago have been realized. In February 2001, Kaiser Permanente signed a 10-year operating agreement with Broadlane under which Broadlane took direct responsibility for much of the provider's national supply chain sourcing and contracting. As required under the agreement, a competitive assessment and audit of Broadlane's pricing would be conducted in the fourth year of the agreement. Key achievements of the partnership in the first three years include: delivering more than $100 million in financial benefits to Kaiser Permanente (including price improvements, rebates, administrative fees and savings in overhead costs); exceeding Kaiser Permanente's price reduction goal of 5 percent; reducing by 33 percent the number of days to complete a national contract for Kaiser Permanente; doubling Kaiser Permanente's contract coverage for medical/surgical and business products to 80 percent; and negotiating 393 contracts in three years, including 118 custom contracts.

The Senate passed by voice vote a bill that would expand Medicaid coverage to "hundreds of thousands" of middle-income families with disabled children. The Family Opportunity Act, sponsored by Senate Finance Committee Chair Chuck Grassley (R-Iowa), would allow families with annual incomes up to 250% of the federal poverty level, or $47,125 for a family of four, to buy into Medicaid for their disabled children. Medicaid offers more comprehensive benefits than most private health plans. Under the bill, states would charge families premiums for Medicaid coverage on a sliding scale and would have discretion in how they operate the program. Private insurance and Medicaid premiums combined could not exceed 7.5% of family income. The bill, which would cost approximately $7 billion over 10 years, also would establish information centers to help families with disabled children obtain information about services and programs available to them.

Consorta has signed three, three-year agreements with GE Healthcare, effective April 1, 2004. Through a sole source agreement, GE will provide its Critikon® blood pressure cuffs to Consorta’s membership. The reusable and disposable blood pressure cuffs are 100 percent latex free. Through two additional multi-source agreements, GE will provide its patient monitoring systems, MUSE® cardiology information system and MAC® ECG systems to Consorta’s member hospitals. One agreement covers specific physiological monitoring technology, including GE’s DINAMAP® patient monitors, QS® fetal monitoring products and invasive cardiology technology for both hemodynamic and electrophysiological labs. The MUSE and MAC ECG Systems are included in a separate agreement.

Derma Sciences announces new multi-year
agreement with Premier

Derma Sciences, Inc., a manufacturer and full line supplier of wound and skin care products, announced a new multi year supply agreement with Premier Purchasing Partners, LP. The new three-year, multi-source agreement is effective June 1, 2004. The supply agreement will offer Premier's members Derma Sciences wide selection of Patient Bathing formulations for hair and body cleansing including Soft Wash® single use bath sponge. As part of the agreement, Derma Sciences will also provide its skin care products, including the patented Dermagran® formulas and perineal skin cleansers.

HPN invites Materials/Purchasing Managers and their staffs to attend the 2004 Critical Care Exposition at the Orange County Convention Center in Orlando, FL, May 18-20 on a complimentary (fee-waived) admission basis.

Wed., May 19 9:00-10:00 am
"How Purchasing Managers and Nurses Collaborate on Effective Buying Strategies"

Thurs., May 20 7:45-9:00 am

"How Nurses and Materials Managers Can Improve Supply Chain/Inventory Issues Affecting Patient Care"

You and your staff are encouraged to visit the show (free admission) and examine firsthand the critical care devices and equipment your nurses use everyday. To receive your NTI 2004 materials, send an email to exhibits@aacn.org or call toll free at 800/394-5995, ext. 366 to request the HPN Registration Special today!

HHS Secretary Tommy Thompson has appointed David Brailer, M.D., to serve as national health information technology coordinator, a position created by President Bush to coordinate the nation's health information technology efforts. Brailer is a senior fellow at Health Technology Center in San Francisco, where he has advised various regional and national efforts on IT and health information exchange. His office at HHS will support government and private sector efforts to develop standards and infrastructure to effectively use IT to promote quality care and reduce healthcare costs. The announcement was made at a Summit made up of healthcare IT leaders. Also, the Health Level 7 standards-setting organization voted favorably on a functional model and standards for an electronic health record, which Thompson said was a significant step in establishing nationwide EHR guidelines. For more on the summit and the announcement, go to http://www.hhs.gov.

Researchers in China say they have found the SARS virus in sweat glands, raising fears that contact such as a handshake might spread the disease. From autopsies of four people who died from the disease, scientists from the First Military Medical University in Guangzhou, China, also found the virus in the intestine, kidney, stomach, lungs, pituitary gland and other organs. The findings are published in the Journal of Pathology, of the Pathological Society of Great Britain and Ireland. Doctors believe SARS spreads mainly through infected airborne droplets. Findings by the researchers suggest the disease may spread through other means, including contaminated food and water, or touching. “If this transmission route is confirmed, new infection- control measures should be recommended,”' lead researcher Yanqing Ding said in the study. “Patients may have to wear gloves, disposable gowns and eye protection, in addition to N95 masks, and to avoid kissing or touching other people.” As expected, the virus was found predominantly in lung tissue of the people who died from SARS, the study showed. The findings also support the theory that the disease can be contracted from feces or urine. The WHO says it's seeking more detail on the research and said it's too early to declare the latest SARS outbreak in China, under control.

U.S. tracking down labs studying SARS

With the recent SARS outbreak traced to labs in Asia studying the virus, U.S. health officials are checking across the country to see which facilities have samples of the virus. Dozens of U.S. laboratories testing the virus will be reminded of safe procedures for handling it, Tom Skinner, spokesman for the U.S. Centers for Disease Control and Prevention, said. "Since laboratory-acquired cases occurred in Asia, we have sent a number of reminders through the health alert network at CDC," he said. Skinner said the CDC had sent samples to 56 labs, most of them in the U.S. Skinner said the Chinese had their own sources of the virus and said various international organizations could supply labs in the U.S. and around the world with SARS. SARS is supposed to be studied in labs with double doors, carefully controlled air flow and special cabinets to prevent splattering.

After researching more than 60 different potential stroke markers, Biosite Incorporated (San Diego, CA), has found a combination of analytes that it believes will help clinicians diagnose the often deadly condition more quickly and accurately. The company plans to submit a point-of-care product to the Food and Drug Administration (FDA) for review at the end of this year; and is continuing research in the area. In the case of ischemic stroke, which accounts for about 80% of all strokes, thrombolytic activator (t-PA) initiated soon after onset can reduce brain injury in many patients, and even save lives. Biochemical stroke markers could be helpful in the 0-6 hour period in which a definitive diagnosis of stroke has not yet been made, says a report in the April issue of Clinical Laboratory Strategies, published by the American Association for Clinical Chemistry (AACC). The report states statistics from the American Stroke Association that the estimated direct and indirect cost of stroke is $53.6 billion per year. Each year, about 700,000 people experience a new or recurrent stroke.

New anthrax detection device

Universal Detection Technology, a company that previously made pollution monitoring equipment, has introduced a device it says is capable of detecting small amounts of anthrax in large buildings. The company says the Anthrax Smoke Detector is ready to be sold commercially and would be tested by the U.S. government for use in government facilities such as post offices. Using a technology developed by NASA's Jet Propulsion Laboratory, the devices are a combination of an air sampler designed to detect air pollution and a spectrometer that can detect molecules found only in bacteria, says the CA-based company.

A new survey by the American College of Healthcare Executives (ACHE) and the American Organization of Nurse Executives (AONE) finds that 99 percent of hospital chief executive officers and 95 percent of chief nursing officers report that their relationship with each other is good. Nearly as many said that the relationship between the CNO and other members of the senior executive management team is also good. The survey studied the responses of 569 CEOs and 460 CNOs.

International experts concluded a three-day international consultation Wednesday on zoonoses, held by the World Health Organization (WHO) together with the Food and Agriculture Organization (FAO) and the World Organization for Animal Health (OIE), in collaboration with the Dutch Health Council. The experts agreed on numerous conclusions and recommendations for the control and possible prevention of future diseases transmitted from animals to humans (zoonoses), such as avian flu and mad cow disease. Conclusions include: recognition that human activities and behaviour drives the emergence of zoonoses, including: pet ownership, interaction with and movement of pets, air travel, food preferences, economic development, and the lack of compliance with recommended prevention measures; the importance of coordinating the response of doctors and veterinarians in outbreak responses to emerging zoonotic diseases; and a recognition that identifying future zoonotic diseases is extremely difficult, due to the complexity of the constantly evolving risk factors. Among recommendations are: encouraging research into surveillance data from non-traditional systems, i.e. insect populations, climactic changes, satellite land observation, and animal and human demographics to attempt to predict future zoonotic public health events; integrating the early warning and alert systems of international organizations (WHO, FAO and OIE) to facilitate detection of potentially linked animal and public health events; and integrating animal and human health data at national and regional levels, including an inter-sectoral committee for zoonosis preparedness and control. For WHO, together with FAO and OIE, the next step forward is to mobilize political awareness and support for the implementation of a public and animal health infrastructure. WHO will also begin coordinating an international network to support countries in analyzing their particular emerging zoonotic disease situation, as well as establish guidelines for the core capacities needed to assess the risk for emerging zoonoses. For more, visit the WHO website at http://www.who.int/en/.

A Libyan court sentenced six Bulgarian medics and a Palestinian doctor to death by firing squad on Thursday for deliberately infecting hundreds of Libyan children with the deadly HIV virus, court officials said. Bulgaria condemned the “unfair and absurd” verdicts and called for a strong reaction from its Western partners: the European Union, NATO and the United States, reports Reuters News Service. Defense lawyers said they would appeal the sentences. The medics had pleaded not guilty, insisting they were not to blame for the epidemic. The health workers, detained in early 1999, were convicted of infecting 426 Libyan children at a Benghazi hospital with blood products contaminated with HIV. More than 40 of the children have died since 1999. Last year Luc Montagnier, the French doctor credited with first discovering the HIV virus, said the epidemic emerged in the hospital in 1997, a year before the medics arrived, probably due to unsanitary conditions, reports Reuters.

The world faces a devastating diabetes epidemic, with the annual death toll already exceeding the three million killed by AIDS and set to rise, the World Health Organization warned Wednesday. Diabetes is growing fastest in poorer countries, with cases seen rising 150 percent over the next 25 years. Furthermore, while in rich states diabetes affects mainly older people, in poorer countries incidence is surging among those still economically active, the two organizations said. “The number is increasing dramatically and has the potential to overwhelm countries' health systems,” WHO director for chronic disease Dr. Robert Beaglehole told a news conference. WHO and the Foundation said they were launching a campaign to raise awareness since diabetes could be prevented by improved eating and exercise habits.

The first clinical management guidelines to address the treatment of
patients with severe sepsis are available for free download. The new guidelines, jointly developed by 10 sponsoring national and international medical organizations include recommendations for antibiotic therapies, intraoptic therapy, DVT prophylaxis and pediatric patient considerations.
See the guidelines on the Society of Critical Care Medicine’s website at http://www.sccm.org/professional_resources/guidelines/
table_of_contents/

The nation’s HMOs reported a $4.3 billion profit during the first six months of 2003, representing a $1.8 billion, or 73.3 percent, jump over the $2.5 billion earned during the same period in 2002, according to Weiss Ratings, Inc. "Aside from the obvious, increased premiums, the performance reported by HMOs reveals how successful the industry has been in streamlining operations and eliminating unprofitable business lines,” commented Melissa Gannon, vice president of Weiss Ratings, Inc. “Meanwhile, escalating healthcare costs have forced many consumers to select insurance based almost entirely on price, rather than on the quality and breadth of coverage.”

Critical care physicians' (often referred to as “intensivists”) estimation of survival were predictive of the need for life support use in the ICU and patient mortality, according to an article in the May issue of Critical Care Medicine. “This paper's observations emphasize that intensivists are much better at predicting who will survive than impersonal numerical scores such as APACHE or organ failure scores,” said Joseph E. Parrillo, M.D., editor-in-chief of Critical Care Medicine. “Intensivists are specially skilled and trained to know who can be 'saved' by present treatment.” The researchers from the Canadian Critical Care Trials Group studied 851 consecutive mechanically ventilated patient admissions to 15 ICUs to evaluate clinical ICU survival predictions and their consequences for ICU patients with a 10% or less clinician estimate of ICU survival probability.

According to a study by the RAND Corporation published Tuesday in the journal Health Affairs, Americans receive substandard healthcare, as defined by leading medical groups, about half the time (50 to 60%), even if they live near a major teaching hospital. The first comprehensive study of healthcare provided in metropolitan areas reviewed medical records of nearly 7,000 people in 12 metropolitan areas, including Newark, Miami and Orange County, CA. The study examined whether patients got recommended treatments for 30 conditions, such as high blood pressure, asthma, breast cancer and depression. It also looked at preventive treatments, such as cancer screening and vaccination efforts. The study's definitions of adequate care were developed from recommendations by specialty medical groups and from four panels of doctors who practiced in a variety of settings. The recommendations reflected standards at the time the care in the study was delivered, from 1996 to 2000. The researchers said that adopting electronic medical records and other computerized tools to help doctors track patient needs and the latest treatment recommendations could significantly help the situation. Dr. Elizabeth A. McGlynn, a researcher at Rand and an author of the study, said, “There's a tremendous explosion in what we know works, but we're still relying on humans to keep track of all that information and use it every time they see a patient. Only a fundamental redesign of the health system will improve the situation.” Dr. McGlynn added, “It’s somewhat outrageous that we can spend $1.4 trillion on healthcare and get it right only half the time. Does that mean to get it right all the time, we have to spend $2.8 trillion? I don't think so.” McGlynn described areas of waste such as repeating tests due to misplaced or unavailable results, surgery when drug treatments would work as well, and unnecessarily prescribing antibiotics.

Kaiser Permanente electronic medical record program goes live

Kaiser Permanente HealthConnect is now online in the 8-million member health plan's Hawaii region. Hawaii becomes the first KP region to go live with the clinical information system that will eventually become the largest single comprehensive electronic medical record system in the U.S., linking clinical information with scheduling, billing and registration data. Kaiser Permanente's local and national information technology teams launched the outpatient system at two ObGyn departments and one primary care clinic on Oahu, and will continue to go live clinic by clinic through 2004. Doctors and nurses using KP HealthConnect will have real-time access to their patients' medical information online in the exam room. They'll know about patients' current and past medical conditions, the drugs they're taking, their allergies and be able to order procedures, prescriptions, and referrals to specialists from the exam room. Nationwide, Kaiser Permanente HealthConnect is an electronic medical records system that will put the program's 12,000 doctors and 8 million patients online within a single software design. Physicians and nurses will be able to see a patient's data and confer in real-time, and with the online launch of member secure internet access early 2005, members will be able to see their own information online at http://www.kp.org.

Pfizer Inc. filed lawsuits against five Internet sites selling a generic version of its cholesterol fighting drug Lipitor, weeks after it sued another Web site for selling the same copycat. The latest suits, filed in federal district courts in Delaware and Connecticut, are against Generic Lipitors (www.genericlipitors.com), Online Rx DrugStore (www.onlinerxdrugstore.com), WorldMedsRX (www.worlmedsrx.com), B. M. International (www.b-m-international.com) and Offshore Pharma (www.offshorepharma.com). New York-based Pfizer said the Web sites are selling U.S. customers a product advertised as Storvas, the brand name of a generic form of Lipitor which is made by Indian drugmaker Ranbaxy Pharmaceuticals Inc. and sold legally in India. Pfizer asked the courts to enjoin continued sales of the product by the sites because no generic form of Lipitor is approved for sale in the U.S. Pfizer also requested damages for infringement of the patent on Lipitor. Pfizer filed a suit on April 12 against the operator of another Web site, look4generics.com (www.look4generics.com) to stop it from selling Storvas to U.S. customers. New Delhi-based Ranbaxy, India's largest pharmaceutical company, said on April 13, it has no connection with look4generics.com and would demand that it stop selling its products, including Storvas.

In a letter of March 25, based on inspections conducted last year, the U.S. Food and Drug Administration said Abbott Laboratories ailed to follow federal quality guidelines for a number of intravenous products, and did not take steps to make sure its manufacturing, packaging and other production systems followed U.S. regulations. The FDA said Abbott continued to distribute about 10 Lifeshield products, a needleless intravenous system, despite lack of quality oversight. FDA regulators also said Abbott did not take steps to verify the sterilization process for certain intravenous materials or check if products purchased elsewhere met federal standards. The FDA said the company failed to set up a system for internal quality audits and worker training, including those who audit suppliers. The letter was posted on the FDA's Web site on Tuesday and is available at www.fda.gov/foi/warning_letters/g4643d.pdf.

The Society of Chest Pain Centers has granted the designation of Accredited Chest Pain Center to Doctors Hospital, making it the second in the Columbus metro area, fourth in Ohio, and 34th in the nation to be accredited. The Chest Pain Center's protocol driven and systematic approach to patient management allows physicians to reduce time to treatment during the critical early stages of a heart attack, when treatments are most effective, and to better monitor patients when it is not clear whether they are having a coronary event. Such observation helps ensure that a patient is neither sent home too early nor needlessly admitted. The Society's accreditation process insures centers meet or exceed quality-of-care measures in acute cardiac medicine.

Thurs., May 20 7:45-9:00 am

"How Nurses and Materials Managers Can Improve Supply Chain/Inventory Issues Affecting Patient Care"

The Medicare discount drug card went on sale Monday amid complaints that some drug prices listed on Medicare’s Web site were inaccurate. After the price comparison feature on the site went live last week, a number of companies offering cards said the prices listed weren't accurate and wanted them corrected before the cards went on sale. Acknowledging there will be “a few bumps in the road,” Health and Human Services Secretary Tommy Thompson encouraged people to compare prices for a couple of weeks before signing up for one of 40 national and 33 regional cards. Once enrolled, people cannot change cards until the end of the year. As of Monday, some of the card sponsors said most of their problems had been resolved. Others were still reporting inaccuracies. It isn't clear whether the site, managed by DestinationRx, is listing prices incorrectly or that variations in package sizes and dosages are making price comparisons difficult and confusing. For more information on the Medicare drug discount card, go to www. medicare.gov or call (800) 633-4227.

Drug manufacturer Schering-Plough Corp. has agreed to pay $27 million to settle allegations it defrauded Texas' Medicaid program. The government accused the company's Warrick Pharmaceuticals unit of submitting false price information that led providers to submit inflated reimbursement claims for drugs used to treat asthma and other respiratory conditions. The government and state of Texas had sought damages of about $106 million in the case. The Justice Department said it would continue investigations into Warrick's actions in other states. The case is the second victory for Texas in its pursuit of what it claims are schemes to falsify the wholesale pricing of generic drugs for Medicaid patients to increase company profits. Last June, Texas reached an $18.5 million settlement with Dey Inc., a unit of Germany's Merck.

National Institutes of Health to hold
hearing on Abbott AIDS drug license

The National Institutes of Health will hold a public hearing next month on a request to allow generic copies of an Abbott Laboratories Inc. AIDS drug, Norvir. Essential Inventions Inc., a nonprofit firm run by consumer activists, has asked the Department of Health and Human Services for a license to produce copies of the drug while it is still under patent. Norvir was developed with support from taxpayer funds and now is being sold at an unreasonable price, the activists argue. Essential Inventions says the 1980 Bayh-Dole Act gives the health secretary power to grant licenses to other producers of patented medicines developed with support from taxpayers. Abbott spokeswoman Jennifer Smoter said the Bayh-Dole Act was intended for use when the public did not have access to an invention supported by taxpayer funds. That is not the case with Norvir, she said. The NIH, in a notice published Wednesday, said it would hold a public meeting May 25 for invited speakers to give input.

Kaiser Permanente has notified 1,331 patients by letter that procedures they had at the HMO's South Sacramento facility may have been done with contaminated instruments. Letters sent Monday, asked patients who had a gastroenterology procedure (endoscopy, colonoscopy or sigmoidoscopy) between Jan. 19 and April 15 to be tested for hepatitis within two weeks. The letters stressed that risk of contracting the disease was “extremely low.” Lung patients who had bronchoscopies are being tested for tuberculosis and other potential infections. “We don't expect any positive test results, but we just felt compelled to do this,” said Dr. Anvar Velgi, chief of infectious disease at the South Sacramento facility. Velgi called for the tests after technicians performing maintenance on two machines used to sterilize the scopes found them to be partially clogged. The clogs may have prevented disinfectant solutions from fully decontaminating the instruments, he said. Velgi said he ruled out testing for HIV, because studies have shown zero risk for HIV transmission through contaminated medical scopes. In response to the problems, Velgi said the machines are being examined every 30 days and that all physicians and nurses who use them are being retrained in sterilization procedures. One month ago, Kaiser's South Sacramento hospital tested more than 1,300 patients who may have been exposed to tuberculosis through contact with an ill nurse.

Kimberly-Clark Health Care has joined with Global Healthcare Exchange, LLC to help further streamline the procurement process and lower costs for customers. Kimberly-Clark Health Care has integrated to GHX’s trading exchange, enabling it to connect to and conduct business electronically with more than 1,700 U.S. hospitals. Kimberly-Clark Health Care customers can improve transaction quality and processing time, while healthcare providers can increase the types of products purchased and the percentage of their overall purchasing using the exchange. Through GHX, healthcare buyers and sellers can conduct business with multiple trading partners through a single Internet connection, eliminating the costs associated with maintaining separate connections with each trading partner. GHX also enables participants to improve supply chain efficiencies by automating manual processes and reducing purchase order errors associated with lack of buyer and seller product data synchronization. Kimberly-Clark is participating in a collaborative effort between GHX and its provider and supplier participants to expand the use of universal product numbers for medical-surgical products.

Lawson Software has signed a new preferred hosting partner agreement with Siemens Medical Solutions Health Services Corporation, replacing the previous 10-year reseller agreement between the companies. As part of the agreement, Siemens becomes Lawson's Preferred Partner for hosting Lawson software applications within the U.S. healthcare market and Lawson becomes Siemens' Preferred ERP vendor for healthcare. Lawson will become responsible for supporting more than 90 clients who are currently using Lawson software currently supported by Siemens. Siemens will continue to provide hosting services to its clients who outsource their Lawson applications to Siemens. All clients, whether hosted or installed, will receive their Lawson application maintenance and support directly from Lawson after a 30-day transition period. Clients will have access to Lawson's Global Support Center for resolution of support issues, direct access to Lawson software products, and direct access to Lawson training, consulting, technical, and product experts.

Union and government officials have reached an agreement to end an illegal hospital walkout that threatened to turn into a general strike. “We have concluded an arrangement, supported by the B.C. Federation of Labor, that will put an end to this dispute,” Premier Gordon Campbell said Sunday. Campbell said the deal was fair and reasonable and should result in a resumption of normal services Monday, reported the Associated Press. The premier chided the Hospital Employees Union for using “patients as hostages” and for making students “pawns.” Since the dispute began April 25, about 6,000 surgeries have been canceled, along with tens of thousands of diagnostic tests such as X-rays, MRIs and CT scans. The deal limits the number of full-time union jobs that local health authorities can contract out to 300 in each of the next two years, a provision union members refused to discuss when it was offered last week, Campbell said. The deal also includes a $25 million (US$18.8 million) severance package for workers laid off between 2002 and 2006, and the union will exercise its right to seek arbitration over the implementation of a 10 percent rollback in members' wages and benefits. Under the deal, neither the union nor its officers will face penalties. Before the settlement, union leaders threatened to try to shut down British Columbia schools and Vancouver-area transit operations Monday. Members of the Canadian Union of Public Employees planned to halt many government services, including garbage pickup in Vancouver, and some forestry operations in Prince George were behind picket lines. After the deal was reached, Neil Worboys, president of the teachers union, said teachers would stay on the job as usual, AP reports.

Disease specialists in Saint John, Canada, are searching for the source of a case of a flesh-eating disease that killed a 37-year-old woman on Friday. Another patient with the disease was upgraded from serious to stable condition Sunday and is in isolation at the Saint John Regional Hospital. Dr. Jim O'Brien, chief of staff at the Atlantic Health Sciences Corporation, said they are trying to find the link between the patients who were infected with the disease, and have enlisted help from Health Canada and the provincial Health Department. O'Brien says both patients were in surgery last Monday and Tuesday but didn't get sick until later in the week. Five other people at the hospital, who were patients at the same day-surgery unit last week, have been put in isolation and doctors are trying to determine whether they also have the disease. The patients are receiving antibiotics as a preventative measure, and officials say no new cases have been detected. “When something like this occurs you look at all aspects of the system including instrumentation and everything else,” O’Brien said. The bacteria, known as group A streptococcus, consumes flesh, often leading to amputation or death. It can be transmitted through body secretions exchanged during close contact. The Atlantic Health Sciences Corporation has set up a toll free number, 1-800-939-9090, for anyone looking for more information.

U.S. health officials now say children aged 6 months to 2 years should get an influenza vaccine annually. “CDC’s Advisory Committee on Immunization Practices, the American Academy of Pediatrics and the American Academy of Family Physicians recommend that, beginning in fall 2004, all children aged 6-23 months, as well as household and out-of-home caregivers for such children receive annual influenza vaccine,” said the Centers for Disease Control and Prevention. The CDC said inactivated flu vaccine is preferred over live, attenuated vaccine for close contacts of severely immunosuppressed persons, including healthcare workers. In addition, healthcare workers receiving live vaccine should refrain from contact with severely immunosuppressed patients for seven days after injection. The CDC had been moving toward the recommendation even before this past flu season’s early onset with a severe species of flu virus that killed at least 142 children under the age of 18, reports Reuters News Service. Influenza and pneumonia are among the top ten leading causes of death for children aged 1 to 4, yet only 10 to 31 percent of children with asthma, which puts them at high risk for flu, get vaccinated. “Healthcare providers are encouraged to order vaccine now and plan pediatric influenza immunization programs to ensure their practices are able to administer vaccine to patients and their direct contacts,” said Dr. William Schaffner of Vanderbilt University School of Medicine in Nashville and a board member of the National Foundation for Infectious Diseases, Reuters reports. For more on the new recommendations, go to http://www.cdc.gov/mmwr/preview/mmwrhtml/rr53e430a1.htm.

The World Health Organization (WHO) and the Chinese Ministry of Public Health wrapped up its two-day survey trip in China's eastern Anhui Province Friday, where two diagnosed SARS cases were found. Jeff Gilbert, a WHO expert on influenza, said the team got the impression that the SARS control measures have been put in place timely in Anhui and local health authorities have taken the issue very seriously. Currently, the SARS epidemic was under control and it was not likely to have another large SARS outbreak, he said. In addition, Gilbert suggested the Chinese government improve SARS monitoring efforts, especially for medical researchers or health staff working at laboratories.

Gerald E. McGinnis, who founded Respironics in 1976 and today serves as Chairman of the Board, was named Washington & Jefferson College’s Entrepreneur of the Year for 2004. Washington & Jefferson College, a liberal arts college founded in 1781 and located in Washington, PA, has honored regional business leaders for lifetime entrepreneurial achievements since 1986. Mr. McGinnis was honored as a man ahead of his time whose “bio-tech start-up” has blossomed into a benchmark of innovation and business building, making him a role model for budding young business people everywhere. On April 21, Mr. McGinnis also received the Entrepreneur Award for Carnegie Science Center Awards for Excellence 2004. The Carnegie Science Center’s Awards for Excellence recognize and celebrate individual achievement in science and technology related fields in Southwestern PA. The awards are intended to raise public awareness about science and its applications in our daily lives. They emphasize the vital links between schools, research laboratories, business development, quality of life and job creation in the region and society at large.

The Centers for Medicare & Medicaid Services has issued a final rule increasing Medicare payment rates for Long-Term Care Hospitals by 3.1% starting July 1 for rate year 2005. A proposed rule released Jan. 30 had projected a 2.9% increase. CMS said the larger increase was largely due to hospitals transitioning more rapidly than expected from a blend of the federal rate and reasonable cost-based payment to 100% of the federal rate. The final rule standardizes the threshold for an interrupted stay (a discharge to an acute care hospital, inpatient rehabilitation facility, skilled nursing facility or patient's home followed by readmission to an LTCH) to three days. The rule also revises the procedure for calculating a hospital's average length of stay for purposes of qualifying for payment under the LTCH PPS. Under the final rule, days will be counted only in the cost-reporting period when the discharge occurs. However, LTCHs will be allowed to meet the existing definition for calculating average length of stay for an additional year if they fail to satisfy the new method. The final rule can be found at http://www.cms.hhs.gov/providers/longterm/frnotices.asp.

Cook Children’s Health Care System in Fort Worth, TX, has installed new medication dispensing technology to create a triangle of checks and balances for improved patient safety. The triangle is the doctor, nurse and pharmacist, said Bob Gronberg, senior director, healthcare information services at Cook. The system provides patient profiling capabilities which alert nurses to potential drug interactions or if a pharmacist hasn’t reviewed a doctor’s prescription orders. The new medication dispensing hardware and software system is manufactured by Omnicell. The drug dispensing cabinets are password-protected and securely locked, have lights to guide nurses to the right medication bins, and are integrated with the hospital’s new information system, according to Gronberg. He said the cabinets have been placed in the bone marrow transplant and the pediatric intensive care units.

New strategic consulting company to address hospital expense control and management

New strategic consulting company to address
hospital expense control and management